UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037057 |
|---|---|
| Receipt number | R000042148 |
| Scientific Title | Stability of brain activation in primary sensory area generated by tactile stimulation in extremities. |
| Date of disclosure of the study information | 2019/06/13 |
| Last modified on | 2022/06/17 14:35:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Stability of brain activation in primary sensory area generated by tactile stimulation in extremities.
Acronym
Stability of activation in primary sensory area
Scientific Title
Stability of brain activation in primary sensory area generated by tactile stimulation in extremities.
Scientific Title:Acronym
Stability of activation in primary sensory area
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the relation of the somatotopic plasticity and tactile function by using fMRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluating point is the temporal difference in activated brain area when upper and lower limb are tactile stimulated.
Evaluating point is the matching degree of the activated brain area and anatomical area.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Sensory stimulation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy females
Key exclusion criteria
1. history of severe systematic / CNS disease.
2. Drug and/or alcoholic abuse.
3. Not adaptable for MRI scanning (e.g. metallic devices, claustrophobia, nyctophobia)
4. Operator's decision as not suitable for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Obata |
Organization
National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Division name
Department of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi
TEL
043-206-3230
obata.takayuki@qst.go.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Sugiyama |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi
TEL
043-206-3230
Homepage URL
sugiyama.satoshi@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secretariat of the Clinical Research Review Committee
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi
Tel
043-206-4709
helsinki@qst.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 13 | Day |
Last modified on
| 2022 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042148
